Market Opportunity

Pulmonary Embolism (PE) is a potentially fatal complication of venous thromboembolism (VTE) and is the leading cause of preventable deaths in US hospitals.1 Compared to the general hospital population, the morbidity and mortality associated with PE among critically ill patients is higher due to elevated thrombosis and bleeding risks among this group, as well as longer lengths of stay (LOS) and higher levels of immobility.

The high incidence of Pulmonary Embolism places a significant burden to the global health care economy driving many governments, including the US, to mandate hospitals to reduce the occurrence of hospital acquired PE.

Overall, as many as 30% of critically ill patients could be at risk for PE.2 In 2012, there were approximately 5.5 million ICU admissions in the US. An analysis of patient claim records shows 250,000 confirmed cases of PE in hospital facilities. When both confirmed and suspected PE are included this number increases to 344,000. Of these PE events, 39% were treated within the ICU.2

In the United States, the average charge billed for an ICU patient without PE is approximately $67,000; however, the occurrence of a PE event drastically increases the charge to approximately $103,000.3 The average length of stay (LOS) for an ICU patient can be reduced by an average of 2.5 days (from 8.1 days to 5.6 days) if PE can be successfully prevented. Patients without PE have significantly better outcomes. The mortality rate for an ICU patient without PE is approximately 6%, which increases to over 12% for patients with PE.2

The Angel® Catheter is intended to reduce the incidence of PE by protecting critically ill patients in the Intensive Care Unit (ICU) who are at high risk. While most hospitalized patients are at risk, there is a portion of under-served patients who are vulnerable to VTE and for whom the current standard of care may not be suitable. These include patients with hemorrhagic stroke, gastrointestinal (GI) bleeds or liver lacerations, neurovascular trauma, hepatic insufficiency, coagulopathy, patients unable to receive anticoagulants, or post-orthopedic surgery patients. Anticoagulation is contraindicated for many in these patient groups, either initially upon admission to the ICU or for the full duration of their ICU or hospital stay.

Global market opportunity for the Angel® Catheter and market growth will be driven by the clear value proposition for the device, convenience and ease-of-placement, the availability of existing reimbursement coverage, and the increasing volume of clinical literature supporting safety and efficacy of the device.